Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-03-01 @ 9:02 PM
Study NCT ID:
NCT03353935
Status:
COMPLETED
Last Update Posted:
2017-11-27
First Post:
2017-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Outcomes After Nerve Sparing Surgery for Deep Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-21', 'studyFirstSubmitDate': '2017-11-21', 'studyFirstSubmitQcDate': '2017-11-21', 'lastUpdatePostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic function', 'timeFrame': '6-12 months', 'description': 'Any change in urinary, sexual or fecal function after surgery, compared to pre-operatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgery', 'pelvic function'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'Patients who underwent surgery for deep endometriosis were submitted to procedures aiming at sparing the pelvic autonomic nervous system. They were observed prospectively followed and interviewed in order to evaluate functional outcomes after surgery.', 'detailedDescription': 'Surgical tretament for deep endometriosis can produce lesions at the level of the pelvic autonomic system.\n\nBefore surgery and 3-12 months after the nerve-sparing surgical procedures, patients were assessed for urinary, sexual and fecal function, in order to evaluate whether sparing of the nerves during the intervention had a beneficial impact on post-operative pelvic function.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoimg nerve-sparing surgery for deep endometriosis were enrolled if they were operated by a single surgeon with extensive background in minimally-invasive pelvic surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Deep endometriosis\n* Surgical treatment\n* Single surgeon\n\nExclusion Criteria:\n\n* Lost to follow-up\n* unwillingness to answer the interview'}, 'identificationModule': {'nctId': 'NCT03353935', 'briefTitle': 'Functional Outcomes After Nerve Sparing Surgery for Deep Endometriosis', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi dell'Insubria"}, 'officialTitle': 'Functional Outcomes of Nerve-sparing Laparoscopic Eradication of Deep Infiltrating Endometriosis: a Prospective Analysis Using Validated Questionnaires', 'orgStudyIdInfo': {'id': '630'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NERVE SPARING', 'description': 'Patients who underwent surgery for deep endometriosis were submitted to surgical procedures aiming at sparing the pelvic ortho- and parasympathetic nerves. The subjects were then followed with interviews using validated questionnaires, to assess the possible changes in post-operative urinary sexual and fecal function.', 'interventionNames': ['Other: Validated questionnaires']}], 'interventions': [{'name': 'Validated questionnaires', 'type': 'OTHER', 'description': 'Patients were administered pre- and post-operatively the three validated questionnaires ((FSFI, ICIQ-UI short form Italian, NBD score) investigating sexual, urinary, and fecal function, respectively.', 'armGroupLabels': ['NERVE SPARING']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'facility': "Department of Obstetrics and Gynecology Universita' Dell'Insubria", 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'overallOfficials': [{'name': 'Stefano Uccella', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Insubria"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Università degli Studi dell'Insubria", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Stefano Uccella', 'investigatorAffiliation': "Università degli Studi dell'Insubria"}}}}